Identity
- Trade Name
- SMARTSKIN+ FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- The Cynosure Smartskin+ system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through an handpiece or a scanning unit. FDA UDI
- Model / Reference
- M079AZ1 FDA UDI
- Description
- The Cynosure Smartskin+ system consists in a carbon dioxide laser (CO2) with 30W of maximum power. The CO2 laser radiation is delivered to the treatment area through an handpiece or a scanning unit. FDA UDI
Identifiers
- Catalog Number
- M079AZ1 FDA UDI
- Primary DI / UDI-DI
- 08057017760139 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dermatological carbon dioxide laser system
Smartskin+ by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological carbon dioxide laser system.
- MedArt Intenz — Medart A/S · Class II
- 5-Pk, external hygienic, CO2RE Intima — Candela Corporation · Class II
- Fraxis Duo ARM — ILOODA.CO., LTD · Class II
- Edge Arm — Jeisys Medical Inc. · Class II
- Standard Hand-piece packing Assy, CO2RE — Candela Corporation · Class II
- Secret PRO Scanner Handpiece — CLASSYS Inc. · Class II
- ATL — Advanced Technology Laser Co., Ltd. · Class II
- Secret PRO Main Unit — CLASSYS Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- El.en. Spa
Sources (1)
- FDA UDI e2463b20-4aa0-4046-8ee6-2a325652b3e2 35 fields · synced Jun 9, 2026